Conference Description:
This 510(k) webinar training will discuss how to do a meaningful result drive 510(k)/change analysis activity so as to satisfy FDA requirements.
Areas Covered in the Seminar:
- Key requirements of the three types of 510(k)s.
- Product changes and filing a new 510(k) – who’s responsible.
- U.S. FDA device clearance / approval.
- Using FDA's K97-1 Memo.
- Tracking and evaluating changes – the “tipping point”.
- Making the process "risk based".
- Documenting the process and rationale.
- Resolving a "wrong" decision .
Who Will Benefit:
All personnel involved in a U.S. FDA-regulated environment especially those involved in new product development, line extensions, and incremental product improvements, having to evaluate those changes to existing FDA-cleared 510(K)'s, and then document their decisions in harmony with regulations:
- Senior management
- Regulatory affairs
- Quality Assurance
- Production
- Engineering & R&D
Start Date: 2011-07-26
Last Day: 2011-07-26
Contact Person: Referral
Email: referral@complianceonline.com
Address:
2600 E. Bayshore Road, Palo Alto, CA, 94303, United States
Tel: 650-620-3915
Fax: 650-963-2556
;)
